CHMP recommends approval of subcutaneous Herceptin (Genentech/Roche) for HER+ Breast Cancer
Roche received a positive recommendation from the CHMP for the subcutaneous formulation of Herceptin (trastuzumab) using Halozyme's rHuPH20 (recombinant human hyaluronidase) for the treatment of patients with HER2-positive Breast Cancer in Europe.
A pivotal Phase III HannaH study, conducted in 102 sites outside the US, demonstrated that Herceptin SC may help decrease the time patients spend receiving treatment at a hospital or physician's practice, by reducing the administration time. A typical IV infusion of Herceptin can take 30 to 90 minutes, per dose, whereas the same dose delivered subcutaneously can be administered in two to five minutes by an injection under the skin.
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